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Neurobehavioral Complications in Children Who Were Previously Treated With Steroids and Intrathecal Therapy for Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00085176
First received: June 10, 2004
Last updated: June 14, 2012
Last verified: November 2010
History of Changes

June 10, 2004
June 14, 2012
May 2004
September 2009   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00085176 on ClinicalTrials.gov Archive Site
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Neurobehavioral Complications in Children Who Were Previously Treated With Steroids and Intrathecal Therapy for Acute Lymphoblastic Leukemia
Neurobehavioral Outcomes in Childhood Acute Lymphoblastic Leukemia. A Limited Non-Therapeutic Stucy

RATIONALE: Cancer therapies may affect the ability of a child's brain and central nervous system to function normally. Learning to identify which patients will develop complications may improve the ability of doctors to plan cancer treatment and improve patient quality of life.

PURPOSE: This clinical trial is studying neurobehavioral changes in children who have received steroid therapy or intrathecal therapy for acute lymphoblastic leukemia.

OBJECTIVES:

  • Compare neurobehavioral functioning, specifically memory, attention, executive function, visual-motor integration, and processing speed, in children previously treated with steroids (prednisone vs dexamethasone) and intrathecal therapy (methotrexate alone vs methotrexate, cytarabine, and hydrocortisone) for childhood acute lymphoblastic leukemia.
  • Correlate non-treatment risk factors, such as gender, age at diagnosis, and time since termination of prior therapy, with impaired neurobehavioral function in these patients.
  • Correlate neurobehavioral complications with quality-of-life of these patients.

OUTLINE: This is a multicenter, cohort study. Patients are assigned to 1 of 2 cohorts (prior treatment per CCG-1922 [prednisone vs dexamethasone] vs prior treatment per CCG-1952 [intrathecal (IT) methotrexate vs IT methotrexate, cytarabine, and hydrocortisone]). Patients in each cohort are stratified according to age at diagnosis, gender, and time since prior treatment termination.

  • Cohort A (CCG-1922): Patients undergo physical and neurological examination, neurobehavioral evaluation, and quality of life assessment. Neurobehavioral evaluations assess memory, attention, and executive function.
  • Cohort B (CCG-1952): Patients undergo evaluation as above. Neurobehavioral evaluations assess visual-motor integration and processing speed.

PROJECTED ACCRUAL: A total of 448 patients (224 per cohort) will be accrued for this study within 4 years.
Interventional
Not Provided
Primary Purpose: Supportive Care
  • Leukemia
  • Long-term Effects Secondary to Cancer Therapy in Children
  • Neurotoxicity
  • Psychosocial Effects of Cancer and Its Treatment
  • Procedure: management of therapy complications
  • Procedure: psychosocial assessment and care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
448
Not Provided
September 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of standard-risk childhood acute lymphoblastic leukemia (ALL)

    • In continuous first remission
    • No history of CNS pathology requiring radiotherapy or surgery

  • Prior enrollment on one of the following Children's Cancer Group (CCG) protocols AND terminated therapy at least 1 year ago:

    • CCG-1922 (prednisone vs dexamethasone)

    • CCG-1952 (intrathecal methotrexate vs triple intrathecal therapy)

      • No prior enrollment on CCG-1952 arm III
  • No history of pre-existing neurodevelopmental disorder before diagnosis of ALL (e.g., mental retardation, Down syndrome, seizure disorder, or traumatic brain injury)
  • No neuropsychological assessment within the past 6 months

PATIENT CHARACTERISTICS:

Age

  • 6.5 to 16 years

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Reading, speaking, and listening comprehension of English by patient required (English and/or Spanish by parent)
  • No history of very low birth weight (< 1,500 grams)

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics

Other

  • Concurrent stimulants allowed
Both
6 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00085176
CDR0000367480, COG-ALTE02C2
Not Provided
Not Provided
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Nina S. Kadan-Lottick, MD, MSPH Yale University
Investigator: Joseph P. Neglia, MD, MPH Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP